Geron prepares for Phase 1 clinical trial

The media is taking a closer look
at the star clinical trial with human embryonic stem cells – a privately-funded
project by the biotechnology company Geron for curing spinal cord injury. In
July the US Food and Drug Administration notified the company that a Phase 1
trial can begin. If the trials fail, private investors would be spooked at a
time when private funding is essential. Apparently no one has been enrolled in
the trial yet.

“There’s a lot
of angst around these trials,” Evan Y. Snyder, of the Sanford-Burnham
Medical Research Institute in San Diego, told the Washington Post. “There’s
going to be this perception that if the cells do not perform well, the entire
field will be illegitimate.” This is particularly true now that a federal
court judge has banned federal funding for the controversial field.

Bioethicists also
worry about whether a recently paralysed young motorcyclist can really give
informed consent to an experimental procedure. He might agree to anything which
promises to save him from a lifetime of paralysis. However, says Hank Greely, a
Stanford lawyer and bioethicist, “If human embryonic stem cells are going
to be useful in treating humans, someone has to be the first one to try it. They
need to have their fingers crossed and hold their lucky rabbit’s foot and be
really careful in their preparations, because before you try something in
humans you never know what’s going to happen.” ~ Washington
Post, Aug 29

Michael Cook
clinical trials
Geron
stem cells

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Michael Cook

Michael Cook edits BioEdge, a bioethics newsletter, and MercatorNet, an on-line magazine whose focus is human dignity. He writes from Sydney, Australia.

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